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Brief Title: Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
Official Title: International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Study ID: NCT00254904
Brief Summary: To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.
Detailed Description: PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pfizer Investigational Site, Birmingham, Alabama, United States
Pfizer Investigational Site, Birmingham, Alabama, United States
Pfizer Investigational Site, Bakersfield, California, United States
Pfizer Investigational Site, St. Joseph, Michigan, United States
Pfizer Investigational Site, Minneapolis, Minnesota, United States
Pfizer Investigational Site, St. Louis, Missouri, United States
Pfizer Investigational Site, St. Louis, Missouri, United States
Pfizer Investigational Site, New York, New York, United States
Pfizer Investigational Site, Spokane, Washington, United States
Pfizer Investigational Site, Spokane, Washington, United States
Pfizer Investigational Site, Innsbruck, , Austria
Pfizer Investigational Site, Bruxelles, , Belgium
Pfizer Investigational Site, Bruxelles, , Belgium
Pfizer Investigational Site, Charleroi, , Belgium
Pfizer Investigational Site, Hasselt, , Belgium
Pfizer Investigational Site, Jette, , Belgium
Pfizer Investigational Site, Leuven, , Belgium
Pfizer Investigational Site, Liege, , Belgium
Pfizer Investigational Site, Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site, Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site, Jau, SP, Brazil
Pfizer Investigational Site, Jaú, SP, Brazil
Pfizer Investigational Site, Jaú, SP, Brazil
Pfizer Investigational Site, Sao Paulo, SP, Brazil
Pfizer Investigational Site, São Paulo, SP, Brazil
Pfizer Investigational Site, São Paulo, SP, Brazil
Pfizer Investigational Site, Toronto, Ontario, Canada
Pfizer Investigational Site, Windsor, Ontario, Canada
Pfizer Investigational Site, Windsor, Ontario, Canada
Pfizer Investigational Site, Greenfield Park, Quebec, Canada
Pfizer Investigational Site, Laval, Quebec, Canada
Pfizer Investigational Site, Levis, Quebec, Canada
Pfizer Investigational Site, Quebec, , Canada
Pfizer Investigational Site, Guangzhou, Guangdong, China
Pfizer Investigational Site, Nanjing, Jiangsu, China
Pfizer Investigational Site, Dalian, Liaoning, China
Pfizer Investigational Site, Beijing, , China
Pfizer Investigational Site, Beijing, , China
Pfizer Investigational Site, Praha 5, CZ, Czech Republic
Pfizer Investigational Site, Olomouc, , Czech Republic
Pfizer Investigational Site, Praha 8, , Czech Republic
Pfizer Investigational Site, Bielefeld, , Germany
Pfizer Investigational Site, Karlsruhe, , Germany
Pfizer Investigational Site, Loewenstein, , Germany
Pfizer Investigational Site, Mannheim, , Germany
Pfizer Investigational Site, Muenchen, , Germany
Pfizer Investigational Site, Tuebingen, , Germany
Pfizer Investigational Site, Kowloon, , Hong Kong
Pfizer Investigational Site, Shatin, , Hong Kong
Pfizer Investigational Site, Zalaegerszeg, Külsőkórház-Pózva, Hungary
Pfizer Investigational Site, Budapest, , Hungary
Pfizer Investigational Site, Deszk, , Hungary
Pfizer Investigational Site, Gyula, , Hungary
Pfizer Investigational Site, Pecs, , Hungary
Pfizer Investigational Site, Bangalore, Karnataka, India
Pfizer Investigational Site, Kochi, Kerala, India
Pfizer Investigational Site, Pune, Maharashtra, India
Pfizer Investigational Site, Ludhiana, Punjab, India
Pfizer Investigational Site, Lucknow, Uttar Pradesh, India
Pfizer Investigational Site, New Delhi, , India
Pfizer Investigational Site, Beer-Sheva, , Israel
Pfizer Investigational Site, Kfar Saba, , Israel
Pfizer Investigational Site, Forli', , Italy
Pfizer Investigational Site, Milano, , Italy
Pfizer Investigational Site, Pisa, , Italy
Pfizer Investigational Site, Roma, , Italy
Pfizer Investigational Site, S.Andrea delle Fratte (PG), , Italy
Pfizer Investigational Site, Gyeonggi-do, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Amsterdam, NH, Netherlands
Pfizer Investigational Site, Zaandam, NH, Netherlands
Pfizer Investigational Site, 's-Hertogenbosch, , Netherlands
Pfizer Investigational Site, Harderwijk, , Netherlands
Pfizer Investigational Site, Nijmegen, , Netherlands
Pfizer Investigational Site, Gdansk, , Poland
Pfizer Investigational Site, Lodz, , Poland
Pfizer Investigational Site, Otwock, , Poland
Pfizer Investigational Site, Szczecin-Zdunowo, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Wodzislaw Sl., , Poland
Pfizer Investigational Site, Coimbra, , Portugal
Pfizer Investigational Site, Lisboa, , Portugal
Pfizer Investigational Site, Lisboa, , Portugal
Pfizer Investigational Site, Lisboa, , Portugal
Pfizer Investigational Site, Porto, , Portugal
Pfizer Investigational Site, Singapore, , Singapore
Pfizer Investigational Site, Bratislava, , Slovakia
Pfizer Investigational Site, Kosice, , Slovakia
Pfizer Investigational Site, Kvetnica pri Poprade, , Slovakia
Pfizer Investigational Site, Nitra-Zobor, , Slovakia
Pfizer Investigational Site, Port Elizabeth, Eastern Cape, South Africa
Pfizer Investigational Site, Cape Town, , South Africa
Pfizer Investigational Site, Port Elizabeth, , South Africa
Pfizer Investigational Site, Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site, Santander, Cantabria, Spain
Pfizer Investigational Site, Baracaldo, Vizcaya, Spain
Pfizer Investigational Site, Alicante, , Spain
Pfizer Investigational Site, Castellon, , Spain
Pfizer Investigational Site, Gerona, , Spain
Pfizer Investigational Site, Jaen, , Spain
Pfizer Investigational Site, Taichung, , Taiwan
Pfizer Investigational Site, Tainan, , Taiwan
Pfizer Investigational Site, Taipei, , Taiwan
Pfizer Investigational Site, Taipei, , Taiwan
Pfizer Investigational Site, Ankara, , Turkey
Pfizer Investigational Site, Bornova / Izmir, , Turkey
Pfizer Investigational Site, Istanbul / Ceraahpasa, , Turkey
Pfizer Investigational Site, Bristol, Avon, United Kingdom
Pfizer Investigational Site, Southampton, Hampshire, United Kingdom
Pfizer Investigational Site, Sutton, Surrey, United Kingdom
Pfizer Investigational Site, Belfast, , United Kingdom
Pfizer Investigational Site, Dundee, , United Kingdom
Pfizer Investigational Site, Edinburgh, , United Kingdom
Pfizer Investigational Site, Glasgow, , United Kingdom
Pfizer Investigational Site, Leicester, , United Kingdom
Pfizer Investigational Site, London, , United Kingdom
Pfizer Investigational Site, Wolverhampton, , United Kingdom
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR